Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial
- Study type
- Clinical trial
- Study name
- UKCTOCS
- Design
- Multicentre (13 centres) randomised controlled trial with 2:1:1 randomisation; investigators and participants were aware of the screening type, but the outcomes review committee was masked to randomisation group. Analyses were by intention to screen.
- Sample size
- 202,562 women analysed (of 202,638 randomised)
- Source
- The Lancet · 2021
- Trial registration
- NCT00058032
In plain words
In this large study, more than 200 thousand postmenopausal women were randomly put into three groups: a blood test plus ultrasound every year, ultrasound alone every year, or no screening. About 16 years later, the number of deaths from ovarian cancer in the screened groups was not meaningfully different from the group with no screening. Although screening with the blood test and ultrasound found some cancers at an earlier stage, this did not save more lives. So ovarian cancer screening is not recommended for ordinary women who are not at high risk; if you have a family history or concerns, talk with your doctor.
Key results
Treatment arms and regimens
Annual multimodal screening; 50,625 women (25.0%).
Annual screening with transvaginal ultrasound; 50,623 women (25.0%).
Control group without screening; 101,314 women (50.0%).
Source of the regimen details: Screening intervention; no drugs or doses
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Postmenopausal women aged 50 to 74 years recruited from 13 centres in National Health Service (NHS) trusts in England, Wales and Northern Ireland. Exclusion criteria: bilateral oophorectomy, previous ovarian cancer or active non-ovarian malignancy, or increased familial risk of ovarian cancer. Of 1,243,282 women invited, 202,638 were enrolled and randomised.
Endpoints
Primary endpoint: death from ovarian or tubal cancer (WHO 2014 criteria) up to 30 June 2020. Follow-up was through national registries. Each of the MMS and USS groups was compared separately with the no-screening group using the versatile test. Other measures reported in the abstract included incidence of ovarian or tubal cancer by stage.
Safety and side effects
The abstract does not report information on adverse effects or harms of screening; details are in the full text.
Clinical significance and place in guidelines
According to the authors' conclusion, general population screening for ovarian cancer (with MMS or transvaginal ultrasound) cannot be recommended, because it did not significantly reduce deaths from ovarian and tubal cancer. The trial also shows that a stage shift at diagnosis alone does not necessarily lead to lower mortality, and that cancer mortality should be the primary endpoint of screening trials. The status of these results in clinical guidelines should be checked separately.
Limitations
Investigators and participants were aware of the screening type (the outcomes review committee was masked). The study population was limited to average-risk postmenopausal women aged 50 to 74 years, and women with increased familial risk of ovarian cancer were excluded, so the results cannot be generalised to high-risk women. Other limitations should be checked in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.